Swissôtel Zurich , Zurich, Switzerland
Dec 9 2010 9:00AM - 5:30PM
Since January 2010, Swissmedic accepts electronic-only submissions in eCTD-format. This course will
offer insight into the compilation of the eCTD, share experience and best practice gained during eCTD
submissions in Switzerland, and the eCTD review process. The focus will be on practical experience
gained in preparing and submitting eCTDs to Swissmedic.
Session 1 – eCTD Fundamentals
- eCTD structure and XML backbone
- Envelope information, meta data, and checksums
- Submission ready documents and granularity
- eCTD life cycle
Session 2 – eCTD Submissions in Switzerland - The eCTD programme Swissmedic
- Swiss specifications and guidelines
- Swissmedic‘s experiences with eCTD submissions
Session 3 – Case Studies - Experiences with applicants
- Preparation of the Swiss Module 1 for eCTD
- Technical correctness of Swiss eCTDs
Session 4 – Practical - eCTD creation and assembly
- Hyperlinking and publishing process
- eCTD life cycle
Event Code:
10572
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